K233768 is an FDA 510(k) clearance for the Papacarie Duo. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Elevate Oral Care (West Palm Beach, US). The FDA issued a Cleared decision on July 18, 2024, 237 days after receiving the submission on November 24, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K233768 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2023 |
| Decision Date | July 18, 2024 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LBH — Varnish, Cavity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3260 |